Experience

Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr. Validation Lead

  • Jan 2018 - Present

• Sr. Validation Lead

  • Jan 2018 - Present

  Project 1: Objective of this project was to assure the systems in use are in compliance of 21 CFR guidelines. The major systems include TrackWise (Version 7.0) and various standalone systems.Project 2: I was involved in performing GAP Analysis and planning a Remediation for the GAP to achieve compliance with FDA regulations and industry standards by overlooking to the computer system validation of the companyResponsibilities:• Documented all aspects of the computer systems Life Cycle (SDLC), in accordance with FDA regulations, particularly 21 CFR Part 11. • Interacted with the Developers and Subject Matter Experts (SME) to better understand the workflow and functionalities on different modules • Prepared and/or reviewed deliverables associated with validation activities. Analyzed User and Functional Requirements to point out Gaps between critical functions of the system against predetermined system design.• Conducted Gap Analysis for reporting purposes which helped in ascertaining the true milestones for the project • Wrote documentation for computer Validation life cycle, in accordance with FDA regulations including validation plan and IQ/OQ/PQ protocols. • Prepared the Remediation Plans to fulfill the gaps that was present in the system. • Assisted in determination of the need for Validation, and when appropriate, the generation of “no validation required” rationales. • Provided reports regarding Validation activities and status.• Proficient in writing Requirements Traceability Matrix (RTM) to track requirements during the entire testing process.• Managed all the change control records also approved a few change requests. • Supported Risk Management and CAPA through customer complaints / root cause investigations and trending analysis Show less



Shire Pharmaceuticals

• Massachusetts, United States

• Sr. Validation Lead

  • Mar 2016 - Jan 2018

  Project – RnD Smart Supplies and Medical Information Cloud upgrade. Responsibilities: • Author, review, and approved all CSV and validation related documents such as URS, FS , DS , TM and RA . • Using Computer System Validation (CSV), Process Validation and Equipment Validation lifecycle, including Validation Masterplan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary Report (VSR) etc., among others. • Work closely with the project team to determine the Validation approach and provide guidance throughout the project. • Create and execute URS, IQ, OQ, PQ, Risk assessments. • Drafted IQ test cases for verifying configuration of Track wise workflows. • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems which include use of hardware, operating systems and languages, software tools and technologies such as IT compliance 21 CFR Part 11(Electronic Records, Electronic Signatures, Audit Trails and Security events) 21 CFR Part 210, Part 211, Part 820 regulation. • Prepared computer System Validation documentation such as User and Functional Requirements Document, Test Plan, Test Scripts and Validation Test Summary Report ALM. • Analyzed the User Requirements Specification Document with Business Analyst and System Owner to incorporate the compliance requirements. • Prepared Traceability documents following for Pharmaceuticals systems development life cycle (SDLC) process. • Generated various validation documents including Validation Plans, Risk Assessments, URS, FRS, IOQs, Trace Matrix and Validation Summary Reports Pro GxP/GxP Admin software • Created Test Plan to validate that the system meets Functional Requirements and complies with the current regulatory quality requirements. • Authored, reviewed, and approved documents collaboratively using myCIMS quality docs. Show less



Baxalta

• United States
• Biotechnology
• 200 - 300 Employee

• Validation Lead

  • Apr 2015 - Mar 2016

  Project 1: I was involved in the validation of Electronic Document Management System (EDMS), Documentum and workspace. Responsibilities: • Involved in preparing documentation for all aspects of the computer system validation lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11 including Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification. • Reviewed, authored several Test Protocols, and performed Test method validations (TMV). • Responsible for execution during the installation, maintenance, qualification, and validation of upgrades for legacy Automation and Quality Systems, including solutions such as LIMS and also including standalone computers and lab equipment software's. • Support Qualification executions during Serialization system/equipment implementation and integration to IT servers. • Handled Product complaints and initiated CAPA. • Analyzed and implemented the Company's Computer Systems Validation Policy and Computer Systems Change Control Policy. • Prepared and reviewed Validation Master Plan (VMP) and Validation Summary Report (VSR). • Followed SDLC Methodologies and industry standard practices to Validate Computer Systems. • Gathered, analyzed, created and documented Functional Requirements Specifications (FRS) and User Requirements Specifications (URS) for various systems. Project 2: I was involved in validation of Labware LIMS (Laboratory Information Management Systems) used for research applications. The project involved gathering the requirements to build specifications and generating reports in accordance with the FDA regulations and CFR 21 Part 11 Standards. Responsibilities: • Author, review, and approve all CSV and Validation related documents such as User Requirements and Functional Requirements. Show less